Multiple ratio fluid dispenser

ABSTRACT

A double syringe delivery system is disclosed for holding a pair of syringes in a manner so as to accommodate the simultaneous activation of the plunger of each syringe in order to effect simultaneous delivery of the contents of each syringe. The delivery system includes a delivery mechanism for delivering the contents of both syringes to a site of application. The delivery system further includes a support member that is positioned between the two syringe bodies. The elongated support member has resilient, C-shaped clamps on one end of the support member. The clamps are designed to be removably clamped onto the applicator so that the syringe barrels will be held together in a parallel manner. The elongated support member further comprises finger grips. A plunger connects the two syringe plungers so that they can also be simultaneously activated.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent applicationSer. No. 10/212,430, filed Aug. 5, 2002, which claims priority to U.S.Provisional Patent Application Ser. No. 60/388,822, filed Jun. 14, 2002.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The invention is in the field of systems utilized to measure outand mix two or more fluids, including freely flowing fluids and viscousfluids, by delivering them simultaneously to a single location. Moreparticularly, the invention's field concerns systems for simultaneouslydispensing two nonhomogeneous materials from two syringes.

[0004] 2. Description of the Prior Art

[0005] There are many types of procedures that require the mixing of twoor more substances before the mixed compound can be used. For example,in the field of dentistry a common practice in the dental arts is tomeasure separate substances, drop-wise, into a well or mixing dish andto then mix the separate substances together using an applicator brush,which in turn is then used to apply the mixed compound to teethsurfaces. More recently, more advanced mixing and delivery applicatorsyringes have been devised that permit mixing to occur within the samesyringe used for delivery. As will be appreciated, in dentistry, it isoften necessary to mix relatively small amounts because of the smallsurface areas that are to be worked upon. Furthermore, the materialswhich are mixed are often expensive, and rather than mix largequantities, relatively small quantities are mixed repeatedly so as tonot waste undue amounts of the materials in question.

[0006] There are circumstances in which it is desirable to dispenseliquid or semi-liquid materials in a predetermined ratio. The materialsmay include reactive, two component adhesives, sealants, coating, orpotting compounds, in which one material may comprise a resin compoundand the other material a catalyst.

[0007] Clotting of blood in vivo takes place by conversion of thesoluble plasma protein fibrinogen into fibrin, which spontaneouslypolymerizes into an insoluble gel matrix which may attach to adjacenttissue. The gel matrix stops bleeding and stabilizes structures.Thrombin catalyzed conversion of fibrinogen to fibrin can be reproducedin vitro and has great utility for adhering tissues and achievinghemostasis. Such fibrin sealants and fibrin glues are availablecommercially and are also made in blood processing laboratories.Preparation and use of fibrinogen-based sealants have been extensivelyreviewed.

[0008] Fibrin sealants, fibrin glues and adhesives based on combiningfibrinogen-containing solutions with thrombin-containing solutions areused to reduce bleeding and restore hemostasis during surgicalprocedures. They have been known and in use for many years during whichtechnology has evolved significantly. For example, fibrin clots can bemade using different concentrations of fibrinogen in conjunction withthe thrombin solution. Subsequent developments in technology includecryoprecipitate fibrinogen. Concentrated plasma can be used as thefibrinogen component in fibrin sealants.

[0009] Similarly, various types of applicators for fibrin glue areknown. An optimal design is not obvious because of the chemical andbiological properties of the liquid resulting from combining fibrinogenand thrombin solutions. Because of the rapid polymerization uponintimate interaction of fibrinogen and thrombin, it is important to keepseparate these two blood proteins until application to the site of use.In practice, the two components are typically dispensed simultaneouslyfrom separate syringes and brought together by means of an applicatormanifold.

[0010] With the known assemblies, a generally trough- or sleeve-shapedretaining means including appropriate troughs or sleeves for receivingthe syringe bodies is provided to connect the syringe bodies, whichretaining means, in addition, is provided with finger grips laterallyprojecting in opposite directions. The syringe bodies are inserted inthese retaining means, wherein for instance, elastically yieldingsnap-in projections hold fast the syringe bodies. To actuate the pistonsof the syringe bodies, the piston rods that are firmly connected withthe pistons, furthermore, are connected with a common grip element, and,for stabilizing and improving the guidance of the piston rods whenactuating the syringe device, it has also been proposed to connect aguide rod with the common grip element; such guide rod extends through aguide bore within the retaining means.

[0011] By such a design, a substantial progress in terms of simplemounting and greater safety in manipulation has been achieved ascompared to earlier designs, such as according to U.S. Pat. No.3,223,083 or U.S. Pat. No. 2,112,160, since, on the one hand, thesyringe bodies may, for instance, be snapped in the retaining means and,on the other hand, the piston rods are interconnected for jointlyoperating the pistons and, moreover, are guided by the guide rod whenmoved such that a uniform actuation of the pistons of all of the syringebodies will be ensured. By contrast, with the arrangement according toU.S. Pat. No. 2,112,160, the syringe bodies, which directly contact eachother longitudinally, are connected in a complex manner by a cement massas well as by wire loops and rubber bands. With the arrangementaccording to U.S. Pat. No. 3,223,083, the syringe bodies are connectedwith one another by a clamp enclosing them on a central point, whereinthe syringe bodies do not assume a stable position relative to oneanother. Moreover, the two piston rods must be pushed forward by theuser simultaneously and as uniformly as possible, which requires greatskill.

[0012] In U.S. Pat. No. 5,290,259, there is disclosed a double syringedelivery system for holding a pair of syringes in a manner so as toaccommodate the simultaneous activation of the plunger of each syringein order to effect simultaneous delivery of the contents of eachsyringe, each syringe containing different contents. The double syringedelivery system includes an elongated support member that is placedbetween the barrel of each syringe. The elongated support member hasresilient, C-shaped clamps on opposite sides of the support member. Theclamps are used for holding the syringe barrels of both syringes so thatthe syringe barrels will be held together in a parallel manner. Further,elongated support member and clamps hold the syringe barrels in afashion that is slightly longitudinally offset from one another topermit the two syringe barrels to be held together as closely aspossible. An interconnecting bridge member connects the two syringeplungers so that they can also be simultaneously activated even thoughthey are also slightly longitudinally offset from one another.

SUMMARY OF THE INVENTION

[0013] The present invention provides a double syringe delivery systemthat seeks to overcome many of the problems and disadvantagesexperienced in the prior state of the art. The double syringe deliverysystem of the present invention is useful in any art in which twononhomogeneous components must be kept separate and are deliveredseparately but simultaneously, wherein the individual components arecombined at the delivery site. Non-limiting examples of such fieldsinclude the production of fibrin glue (e.g., by simultaneouslydelivering fibrinogen-containing solutions with thrombin-containingsolutions from separate syringes), and the field of dentistry.

[0014] More specifically, the present invention provides a dual syringedelivery system designed so that it can be gripped comfortably and whichpermits simultaneous application of the two nonhomogeneous materialscontained in two separated syringes. The apparatus is comprises of apair of syringe bodies which are held in parallel relationship withrespect to one another by a holding mechanism and a plunger clip. Thedelivery ends of the individual syringe bodies are connected to adelivery mechanism. The plunger clip allows for even, simultaneous andaccurate delivery of the separate components contained in each syringebody.

[0015] A further aspect of the present invention is to provide a doublesyringe delivery system capable of utilizing two standard syringes ofdifferent lengths, wherein the syringe plungers are locked together witha plunger clip designed to accommodate the offset relationship of theplungers so that the syringe plungers can be simultaneously activated toexpel all of the contents of the fluids contained in both syringes.

[0016] Briefly described, in one embodiment of the double syringedelivery system of the present invention, the delivery system comprisesa holding mechanism having an elongated support member that isinterposed between the syringe barrels of two standard syringes. Theelongated support member has two resilient C-shaped clamps which arespaced from on one end of the support member. The C-shaped clamps can besnapped onto a delivery tip that is connected to the syringe barrels ofeach of the syringes. In this fashion, the two syringes will be heldtogether in a parallel manner. Also attached to the support member aretwo finger grips to aid in the delivery of the syringe contents. Thedouble syringe delivery system also comprises a plunger clip thatattaches to the end of the syringe plungers so as to join the syringeplungers together to permit simultaneous actuation of the syringeplungers. Since the holding mechanism attaches to the delivery tiprather than the syringes, the dual syringe delivery system of thisinvention is independent of syringe size or length. Accordingly, anycombination of syringe sizes can be attached to the delivery tip withoutrequiring design changes to the holding mechanism.

[0017] The delivery system of this invention further comprises a syringeplunger clip. The clip attaches the two plungers together for even andaccurate delivery of the two components. A key feature to this design isthe offset of the two slots to compensate for the difference in lengthof the two syringes. The offset is set to ensure each syringe is emptiedat the same time without residual fluid remaining in either syringe.

[0018] In one embodiment, the present invention relates to a deliverysystem for applying a tissue adhesive. More particularly, the tissueadhesive is comprised of a first solution containing fibrinogen and asecond solution containing thrombin. The delivery system is used to keepthese two solutions separate until they are applied together at atreatment site to seal a wound, stop bleeding or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated herein and forma part of the specification, illustrate preferred embodiments of thepresent invention, and together with the description, serve to explainthe principles of the invention.

[0020] In the Drawings:

[0021]FIG. 1 is a plan view of a delivery system of this inventionassembled with two syringes.

[0022]FIG. 2 is an exploded view of a delivery system of this inventionshowing the individual components.

[0023]FIG. 3 is side plan view of one embodiment of a plunger clip ofthis invention.

[0024]FIG. 4 is a side plan view of the plunger clip of FIG. 3.

[0025]FIG. 5 is a side plan view of an alternative plunger clip of thisinvention.

[0026]FIG. 6 is an exploded view of one embodiment of a plunger clip andan insert for one of the clip grooves.

[0027]FIG. 7 is an exploded view of one embodiment of a plunger clip andan alternative insert for one of the clip grooves.

[0028]FIG. 8 a perspective view of an offset plunger clip of thisinvention.

[0029]FIG. 9 is a perspective view of an offset plunger clip of thisinvention, showing a ratchet system.

[0030]FIG. 10 is a perspective view of an adjustable offset plunger clipof this invention shown in FIG. 9 cut away along lines 10 of FIG. 9.

[0031]FIG. 11 is a cross-sectional view of one embodiment of a deliverysystem of this invention for the delivery of an autologous fibrinsealant.

DETAILED DESCRIPTION OF THE INVENTION

[0032]FIGS. 1 and 2 illustrate one embodiment of a double syringedelivery system in accordance with present invention, as generallyindicated at reference numeral 5. The double syringe delivery system isused for holding a pair of standard syringes in a manner so as toaccommodate simultaneous activation of the plunger of each syringe inorder to effect simultaneous delivery of the contents of each syringebarrel.

[0033] As shown in FIGS. 1 and 2, the apparatus of the present inventioncomprises a pair of syringes (10, 20). Each syringe (10, 20) has asyringe barrel (11, 21) from which fluid is to be dispensed. Thesyringes (10, 20) can either be the same size or can be different sizesand/or lengths. Associated with each syringe barrel is a syringe plunger(15, 25) which is inserted into the end of the syringe barrel (11, 21)in standard fashion so that as the syringe plunger (15, 25) is pushedinto the barrel (11, 21), the fluid contents of the barrel (11, 21) aredispensed. The overall length of plunger 15 can be the same as, ordifferent than, the overall length of plunger 25. Each of the plungershas an elongated shaft (16, 26) and a push flange (18, 28) at theproximal end of the plunger shaft. The push flanges (18, 28) are heldtogether by plunger clip 40 so that the two plungers can be actuatedsimultaneously. Plunger clip 40 is designed to accommodate any sizesyringe plunger, and ensures that the distal ends of the plungers arealigned with each other, as will be hereinafter more fully described.Each syringe barrel (11, 21) has a standard luer connector or conus (12,22) at the delivery end of the barrel (11, 21). In the illustratedembodiment, the luer connectors (12, 22) are standard threaded femaleluer connectors.

[0034] Delivery apparatus 5 further comprises delivery tip 70 comprisinga pair of connectors (71, 72) such as corresponding male luer connectorsfor the barrel connectors (12, 22). Connectors 71,72 are used to attachapplication tip 70 to the coni or luer connectors 12, 22 of the syringebarrels. Attached to each connector 71, 72 of the delivery tip is aseparate cannula 73, 74, respectively, through which the fluid contentof the corresponding syringe 10, 20 is expelled. The distal ends of thecannulas (73, 74) are aligned with each other so that there will besimultaneous delivery of the separated fluids from both syringes to theapplication site. Delivery tip connectors 71, 72 have a central lumentherethrough which is in communication with each interchamber of thesyringe body and with the cannula (73, 74) associated with eachconnector.

[0035] In one embodiment, cannulas 73, 74 comprise needles ofsubstantially equal length. Each of these needles 73, 74 is bent towardseach other to that as the needles approach their distal ends, they runparallel to each other and touch. The parallel portions of needles 73,74 can be joined together with a sleeve, adhesive, or other methodsknown in the art. In another embodiment, cannula 73, 74 compriseflexible tubing which are cut off at equivalent lengths and attached attheir distal ends, usually with solvent adhesive. In yet anotherembodiment, delivery tip 70 comprises a hollowed double fluid pathattached to a single cannula fitting 75 such as that described in U.S.Pat. No. 5,104,375, which is specifically incorporated herein byreference.

[0036] Alternatively, the barrel connectors or coni (12, 22) can beattached to a spraying head device. Spraying heads for delivering fluidsfrom syringes are well known in the art.

[0037] Another important feature of the present invention is theremovable holding mechanism 30, as shown in FIGS. 1 and 2. Holdingmechanism 30 includes integrally formed lateral finger grips 32, 33which project outwardly from the proximal end of an elongated supportmember 31 of holding mechanism 30. The finger grips (32, 33) provide ameans by which the apparatus can be gripped comfortably by the user inany number of angular orientations. In one embodiment, a bridge member36 is integrally formed between the finger grips (32, 33). When thedelivery apparatus is assembled, support member 31 is positioned betweenthe syringes (10, 20), and the finger grips (32, 33) project in a planethat is perpendicular to the syringes (10, 20) to reduce the width andoverall profile of the dual syringe delivery system 5.

[0038] The holding mechanism 30 further comprises a collar means at thedistal end of the support member 31. With reference to FIG. 2, thecollar means is comprised of two resilient C-shaped clamps (35, 36) thatcan be removably snapped onto the connectors (71, 72) of delivery tip 70for purposes of securely holding the syringes (10, 20) in asubstantially parallel manner, and so that the delivery ends of thesyringes (10, 20) are aligned with each other. In the embodiment shownin FIG. 2, C-shaped clamps 35 and 36 are formed on either end of bridge37, which is perpendicularly formed at the distal end of support member31. The width of each clamp (35, 36) is large enough so that each clampcan be snapped onto a connector (71, 72) of the delivery tip 70, butnarrow enough to ensure a secure fit. As will be further appreciatedfrom FIGS. 1 and 2, the entire holding mechanism 30 is preferablyconstructed as a unitary, molded plastic piece which has sufficientresilience or memory so that the C-shaped clamps (35, 36) can be easilysnapped onto and off of the delivery tip 70, thus permittinginterchangeability of the syringes (10, 20) without disassembling theentire delivery apparatus.

[0039] In one embodiment, each C-shaped clamp (35, 36) includes a knob(38, 39) integrally formed approximately midway between the ends of theclamp and projecting towards the delivery tip 70. The knobs (38, 39)serve to stabilize holding mechanism 30 during use of the deliverysystem 5 of this invention.

[0040] Since holding mechanism 30 of this invention is secured to theconnectors (71, 72) of the delivery tip 70 rather than to the syringebarrels 11, 21, the delivery system of this invention is independent ofsyringe size. Accordingly, any combination of syringe sizes can beutilized in the delivery apparatus 5 of this invention without requiringdesign changes to holding mechanism 30.

[0041] In one embodiment of this invention, holding mechanism 30 anddelivery tip 70 integral, i.e., they are formed as a unitary, moldedpiece.

[0042] The delivery system 5 of this invention further comprises asyringe plunger clip 40. Plunger clip 40 is removably secured to theflange (18, 28) of each syringe plunger (15, 25) and provides a surfaceagainst which the finger(s) of a user can be pushed when exertingpressure on the plungers (15, 25). Plunger clip 40 thus aids thesimultaneous actuation of the plungers (15, 25) with equal stroke.Plunger clip 40 has a unique configuration which permits it to beslipped onto and off of the push flanges (18, 28) by the user withouthaving to disassemble the entire delivery device. In addition, plungerclip 40 is able to compensate for the difference in length when syringes10, 20 are different lengths as described hereinafter in detail. Thisfeature ensures that each syringe is emptied at the same time withoutresidual fluid remaining in either syringe, regardless of the size ofthe syringe.

[0043] With reference to FIGS. 3 and 4, one embodiment of plunger clip40 comprises a solid top member 41, one or more side members 44projecting downwardly from at least one, but less than all, of the sidesof top member 41, and a base member 48 which projects from side member44 and is substantially parallel to the top member 41, forming a gap 49therebetween. In one embodiment, members 41, 44 and 48 are all formed asa unitary, molded plastic piece. Base member 48 also includes grooves 52and 54 for receiving push flanges 18 and 28, respectively. In oneembodiment, grooves 52, 54 are proportioned so they are larger than thediameter of plunger shafts 16 and 26, but smaller than the diameter ofpush flanges 18 and 28. This configuration permits the push flanges tobe removably yet securely clipped within and retained by plunger grip 40so that the two plungers (15, 25) can be actuated simultaneously. Thedistance between grooves 52, 54 is wide enough to allow support member31 to be positioned between barrels 11, 21 when the device 5 isassembled. Plunger clip 40 is made of a resilient material such as aplastic having sufficient flexibility so that flanges 18, 28 can beinserted into grooves 52, 54, but has sufficient stiffness to ensurethat the flanges are securely retained between top member 41 and basemember 48.

[0044] In the embodiment illustrated in FIG. 4, grooves 52, 54 ofplunger clip 40 have different lengths and/or widths and are sized toaccommodate a pair of syringes of specific yet different sizes. Forexample, in one nonlimiting embodiment, groove 52 is sized to securelyretain the plunger of a 5 mL syringe, and groove 54 is sized to securelyretain the plunger of a 10 mL syringe. In this embodiment, groove 54 iswider than, and optionally longer than, groove 52.

[0045] In an alternative embodiment of plunger clip 40, grooves 52, 54are substantially the same width. By way of illustration only, in oneembodiment of plunger clip 40 the grooves 52, 54 are substantially thesame width and are wide enough to securely retain a plunger of a 20 mLsyringe. In this embodiment, if a smaller syringe (e.g., smaller than a20 mL syringe) having a plunger narrower than a 20 mL syringe isrequired, the narrower syringe plunger can be securely retained byplunger clip 40 by one of several means. One means of retaining thenarrower syringe plunger within plunger clip 40 utilizes a resilientinsert 80 as illustrated in FIG. 6, which can be made of a resilientrubber or plastic material. In the embodiment illustrated in FIG. 6,flexible insert 80 has an overall width wider than the width of groove52 and overall length longer than groove 52. Insert 80 further comprisesgroove 82 having a width that is narrower than the width of groove 52.In use, the insert 80 is inserted into between top member 41 and basemember 48 prior to sliding the push flange of the narrower plunger intogroove 52 so that grooves 52 and 82 are substantially centered. In thismanner, insert 80 essentially narrows the width of the groove into whichthe flange of the narrower plunger is inserted, thereby creating a moresecure fit for the narrower plunger. The flange of the narrower plungeris then inserted into groove 82 between top member 41 and insert 80. Theinsert 80 has sufficient flexibility to allow a plunger that is slightlywider than groove 82 to be inserted into groove 82, but has sufficientstiffness to ensure that the inserted flange is securely retained.

[0046] An alternative method of retaining a narrower plunger into awider groove 52 of plunger clip 40 having grooves of substantially thesame width is illustrated in FIG. 7. In this embodiment, a ratchetedinsert 90 is provided to ensure a tighter fit of a narrower plunger intoa wider groove 52. With reference to FIG. 7, ratcheted insert 90comprises a curved wall 91 for pressing against the plunger. Insert 90further comprises ratchet teeth 92 extending longitudinally from asecond wall adjacent to the curved wall 91 and having preselectedtransverse spacings therebetween. In this embodiment, groove 52 ofplunger clip 40 further comprises ratchet teeth 93 extendinglongitudinally from the concave side 94 of groove 52. Ratcheted insert90 may be inserted into groove 52 in such a manner that ratchet teeth 92on insert 90 slidingly engage ratchet teeth 93 on the concave side 94 ofgroove 52. Ratchet teeth 92, 93 may be formed such that each ribincludes a vertical and a slanted side when viewed in cross section.Ratchet teeth 92, 93 are ideally constructed such that they slidinglymesh when insert 90 is inserted into gap 52 between top member 41 andbase member 48. Because of the relative orientations of the vertical andslanted sides of ratchet teeth 92 and 93, insert 90 may be irreversiblyinserted into gap 52. Ratchet teeth 92, 93 thus behave like the pawls ofa ratchet, permitting movement in one direction past them, butprohibiting movement past them in the opposite direction. In use, theflange of the narrower plunger is first inserted into groove 92. Insert90 is then inserted into gap 49 from a side adjacent opening 95 ofgroove 52 until curved wall 91 abuts the narrower plunger shaft. In thismanner, the narrower plunger is securely retained by the plunger clip40.

[0047] An alternate embodiment of a delivery apparatus of this inventionutilizes plunger clip 140 as illustrated in FIG. 5. Plunger clip 140comprises a top member 141, a first side member 144 projectingdownwardly from top member 141, and a first base member 148 projectinginwardly from side member 144 and parallel to top member 141, forming agap 149 therebetween. Plunger clip further comprises second side member145 projecting downwardly from top member 141 from a side opposite thatof first side member 144, and a second base member 150 projectinginwardly from side member 145 and parallel to top member 141, forming agap 155 therebetween. Base members 148 and 150 also include grooves 152and 154, respectively, for receiving push flanges 18, 28. Grooves 152,154 of plunger clip 140 open from opposite sides of plunger clip 141. Anadvantage of this design is that the plunger clip 140 can be rotatedabout one of the plungers out of the way of the second plunger, makingit easier to replace the second syringe without disassembling the entiredelivery device. In one embodiment of plunger clip 140, grooves 152 and154 of plunger clip 140 have different lengths and/or widths, andplunger clip 140 is thus designed to accommodate a pair of syringes ofspecific yet different sizes. In an alternative embodiment of plungerclip 140, grooves 152, 154 are substantially the same width, and anarrower syringe plunger can be securely retained by plunger clip 140 byone of several means, such as by utilizing insert 80 (FIG. 6) orratcheted insert 90 (FIG. 7) as described above.

[0048] With reference to FIG. 1, in one method of using the doublesyringe delivery system of the present invention, two standard syringes10, 20 are first obtained and the delivery tips 70 is attached at thedelivery ends of each syringe barrel 11, 21 in the manner described.Each connector 71, 72 of delivery tip 70 is snapped into the tworesilient, C-shaped clamps 38 and 39 of holding mechanism 30 to securethe two syringes 10, 20 in a parallel relationship. The plunger clip 40is secured to the proximal ends of each syringe plunger 15, 25 bysliding the flange 18, 28 of each syringe plunger 15, 25 into grooves52, 54. Syringe plungers 15, 25 can be simultaneously activated bygripping the finger grips 32, 33 with two fingers and pushing againstthe plunger clip 40, for example, with the palm or heal of the hand, inorder to simultaneously express, either drop-wise or faster, the fluidcontents of each syringe 10, 20 which are thereafter mixed at the siteof application. By commonly depressing the respective plungers of thetwo syringes 10, 20, the contents of the separate syringes areexpressed, dispensed or exhausted separately but simultaneously throughtheir corresponding separate cannulas 73, 74. As they are expressed, thetwo separate fluid components merge at the distal terminus of thedelivery tip 70. Thus, when the equivalent amounts of pressure areprovided, the delivery tip 70 is able to deliver the same amount offluid from each syringe 10 and 20.

[0049] In one embodiment, syringes of different lengths may be utilizedin the delivery apparatus of this invention. Since the delivery tip 70always ensures that the delivery ends of the syringes are substantiallyaligned, an alternative plunger clip designed to ensure that thecontents of both syringes are emptied at the same time must be used.Accordingly, in this embodiment, the grooves of the plunger clip areoffset to accommodate syringes of differing lengths.

[0050] One non-limiting example of an offset plunger clip 240 isillustrated in FIG. 8. Plunger clip 240 is designed so that the groovesof the plunger clip are longitudinally offset by an amount that issubstantially the same as the difference in the lengths of the twosyringes. With continued reference to FIG. 8, plunger clip 240 comprisesfirst top member 241, first side member 246 projecting downward from oneedge of top member 241 and a second side member 244 projecting downwardfrom an adjacent edge of top member 241. Plunger clip 240 furthercomprises a second top member 243 extending outward from an edge of sidemember 246 opposite from top member 241 and projecting in a directionopposite that of top member 241. A third side member 245 projectsdownward from another side of second top member 243. Projecting inwardfrom side members 244 and 245 are base members 248 and 250,respectively, forming gaps 260, 261, respectively, therebetween. Thedistance 249 between the top face of top member 241 and the top face oftop member 243 is substantially equal to the difference in lengthbetween two different size syringes barrels 11, 21. Base members 248 and250 also include grooves 252, 254, respectively.

[0051] In one embodiment of plunger clip 240 illustrated in FIG. 8,grooves 252 and 254 of plunger clip 240 have different lengths and/orwidths, and plunger clip 240 is thus designed to accommodate a pair ofsyringes of specific yet different sizes. In an alternative embodimentof plunger clip 240, grooves 252, 254 are substantially the same width,and a narrower syringe plunger can be securely retained by plunger clip240 by one of several means, such as by utilizing insert 80 (FIG. 6) orratcheted insert 90 (FIG. 7) as described above. In yet anotherembodiment of plunger clip 240, the openings of grooves 252 and 254 intowhich the plungers are inserted open in opposite sides of the clip.

[0052] In one embodiment of plunger clip 240, the distance 249 betweentop members 241 and 243 is fixed. Alternatively, the distance 249 ismade variable by employing a ratchet system in a variable plunger clipas illustrated in FIG. 9. As shown in FIG. 9, a unidirectional ratchetsystem is provided by ratchet teeth 292 extending longitudinally fromside member 246 with a preselected transverse spacing therebetween, andtooth 293 extending longitudinally from an edge 270 of top member 243adjacent side member 246 (see FIG. 10). Ratchet teeth 292 and tooth 293may be formed such that each tooth includes a vertical and a slantedside when viewed in cross section. Ratchet teeth 292 and tooth 293 areideally constructed such that they slidingly engage when top member 243is pushed in the direction of top member 241. Because of the relativeorientations of the vertical and slanted sides of ratchet teeth 292 andtooth 293, top member 243 may be moved unidirectionally towards topmember 241, thereby adjusting (i.e., decreasing) distance 249therebetween. When in use, plunger flanges 18 and 28 having differentlengths are inserted into grooves 252 and 254, respectively. Base member243 is then pushed towards base member 241 until the distal ends ofplungers 15 and 25 are aligned with each other. Because of the relativeorientations of the vertical and slanted sides of ratchet teeth 292 andtooth 293, base member 243 cannot be pulled back away from base member241. The plungers 15, 25 are inserted into barrels 11, 21 and fluid istaken up into barrels 11, 21 by pulling on plunger clip 240, therebyactuating plungers 15, 25 simultaneously. To simultaneously express thefluids contained in barrels 11, 21, the user pushes against top member241 of plunger clip 240 in order to avoid changing the adjusted distance249.

[0053] One embodiment of the present invention is directed toward adelivery device for the production of autologous thrombin and autologousplatelet gels. For example, one embodiment the present invention relatesto a two-phase method for forming an autologous bioadhesive sealantcomposition or fibrin glue, wherein all of the blood components for thebioadhesive sealant are derived from a patient to whom the bioadhesivesealant will be applied. This method is similar to that disclosed inU.S. patent application Ser. Nos. 09/063,338 and 10/116,729, each ofwhich is assigned to the assignee of the present invention and isspecifically incorporated herein by reference. Briefly, in oneembodiment a platelet rich plasma is formed by centrifuging a quantityof anticoagulated whole blood that was previously drawn from thepatient. The platelet rich plasma is then divided into two portions. Tothe first portion, which is used in phase-one, a compound that reversesthe effect of the anticoagulant is added, and a clot is allowed to form.The clot is then triturated to produce a serum containing autologousthrombin. The serum obtained from phase-one is then mixed with thesecond portion of the platelet rich plasma in phase-two to form abioadhesive sealant.

[0054] More specifically, and with reference to FIG. 11 the two-phasemethod of forming an autologous platelet gel begins by forminganticoagulated whole blood, which is achieved by collecting a patient'swhole blood in a medium containing an anticoagulation agent, such assodium citrate (citrate) or heparin. The anticoagulated whole blood isnext centrifuged at a rate of approximately 20-50 r.c.f.'s (relativecentrifugal force) for 10-40 minutes, and preferably in a refrigeratedcentrifuge at 25 r.c.f.'s for 20 minutes, resulting in the formation oftwo liquid phases. The top phase is a platelet rich plasma, and thebottom phase is anticoagulated whole blood minus the platelet richplasma. In one embodiment, the platelet rich plasma is then gently drawnoff, divided into two portions and stored in syringes 952 and 960. Theplatelet rich plasma in syringe 952 is used in the first phase of theprocess to prepare the thrombin, while the second portion in syringe 960is utilized in phase two. Syringes 952 and 960 may be either glass orplastic syringes. Preferably, syringe 960 is a plastic syringe.

[0055] Syringe 952 preferably contains a contact activator 953 such as,but not limited to, glass wool, silica, aluminum, diatomaceous earth,kaolin, etc. When syringe 952 is a glass syringe, the inner surface 957of the syringe 952 acts as the contact activator. Chemical activators,such as kaolin, can also be used to speed up the clotting time; however,their subsequent removal would also be necessary.

[0056] Phase one according to one embodiment begins by restoring theclot-forming process. To accomplish this, an agent (restoration agent)capable of reversing the effects of the anticoagulation agent is addedback into the first portion of the platelet rich plasma in syringe 952.If sodium citrate was used as the anticoagulant, the reversal of theanticoagulant is preferably accomplished using calcium chloride.However, any substance that is known or found to be functionallyequivalent to calcium chloride, such as, calcium gluconate, in restoringthe coagulation activity of citrated blood may be used in the practiceof the present invention. Alternatively, if heparin was used as theanticoagulant, then heparinase or any other suitable anticoagulantreversing compound would be used to reverse the effect of theanticoagulation agent. The concentration of the restoration agent usedto reverse the anticoagulation will depend in part, upon theconcentration of the anticoagulation agent in the platelet rich plasmaand the stoichiometry of the chelating and coagulation reactions.However, the concentration of the restoration agent used to reverse theanticoagulation must be sufficient to achieve clot formation.

[0057] Upon restoration of the platelet rich plasma, a clot willnaturally form. The resulting clot is then triturated. In oneembodiment, the clot is triturated by squeezing the clot throughmaterial 953, which in one embodiment is glass wool and thus serves notonly as a contact activator but also as a filter, thus expressingthrombin. Alternatively, or in addition, a filter 958 having a largemicron pore size is positioned downstream of outlet 956 of syringe 952,thereby allowing the removal of clot debris and any activator or solidsthat are present. The thrombin produced in syringe 952 and the secondportion of platelet rich plasma (PRP) contained within syringe 960 arethen expelled through their respective cannulas 73 and 74, whereuponthey combine at the site of application to form the platelet gelcomposition.

[0058] The foregoing description is considered as illustrative only ofthe principles of the invention. Further, since numerous modificationsand changes will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and processshown as described above. Accordingly, all suitable modifications andequivalents may be resorted to falling within the scope of the inventionas defined by the claims that follow.

[0059] The words “comprise,” “comprising,” “include,” “including,” and“includes” when used in this specification and in the following claimsare intended to specify the presence of stated features, integers,components, or steps, but they do not preclude the presence or additionof one or more other features, integers, components, steps, or groupsthereof.

We claim:
 1. A method of delivering a platelet gel composition to atreatment site of a patient comprising: collecting a portion of wholeblood from the patient; adding an anticoagulant to the collected wholeblood; centrifuging the anticoagulated whole blood to form a plateletrich plasma; placing a first portion of the platelet rich plasma in afirst syringe body; placing a second portion of the platelet rich plasmain a second syringe body; adding to the second syringe body an agent forreversing the effects of the anticoagulant in the second portion of theplatelet rich plasma; allowing the second portion of the platelet richplasma to form a clot within the second syringe body; delivering thefirst portion of the platelet rich plasma from the first syringe body tothe treatment site; and delivering simultaneously thrombin from thesecond syringe body to the treatment site, wherein thrombin is formed bytriturating the clot through a filter material, the thrombin and theplatelet rich plasma delivered to the treatment site combine to form theplatelet gel composition.
 2. The method of claim 1 wherein the first andsecond syringe bodies have a luer connector at one end.
 3. The method ofclaim 2 wherein an applicator tip comprising first and second luerfittings is connected to the luer connectors of the first and secondsyringe bodies.
 4. The method of claim 3 further comprising the step ofplacing the first and second syringe bodies in a holding mechanism thatretains the syringe bodies in at least a substantially parallelalignment without contacting said first and second syringe bodies, theholding mechanism comprising an elongated support member positionedbetween the first and second syringe bodies and having a pair ofC-shaped clamps extending laterally from one end of the elongatedsupport member for attachment to the applicator tip luer fittings. 5.The method of claim 1 wherein the first and second syringe bodies havefirst and second plungers, respectively, for delivering from each of thesyringe bodies its associated material, the first and second plungerseach having a push flange and a plunger shaft.
 6. The method of claim 5further comprising the step of placing the push flanges of the first andsecond plungers in a plunger clip having first and second channeledgrooves for securing the plunger push flanges within the first andsecond grooves and actuating the plungers simultaneously.
 7. The methodof claim 6 wherein the first syringe body has a first length and thesecond syringe body has a second length, the first syringe body lengthbeing a different length than the second syringe body length and thefirst and second grooves of the plunger clip are longitudinally offsetby an amount that is substantially the same as the difference in thelengths of the first and second syringe bodies.
 8. The method of claim 1wherein the treatment site is a wound site.
 9. The method of claim 1wherein the anticoagulant is sodium citrate.
 10. The method of claim 1wherein the anticoagulant is heparin.
 11. The method of claim 1 whereinthe anticoagulated whole blood is centrifuged at a rate of aboutapproximately 20 to 50 r.c.f.'s.
 12. The method of claim 1 wherein theanticoagulated whole blood is centrifuged for about approximately 10 to40 minutes.
 13. The method of claim 1 wherein the anticoagulated wholeblood is centrifuged refrigerated at about 25 r.c.f.'s for about 20minutes.
 14. The method of claim 1 wherein the second syringe includes acontact activator to speed up the formation of the clot.
 15. The methodof claim 14 wherein the contact activator is selected from the groupconsisting of glass, glass wool, silica, aluminum, diatomaceous earthand kaolin.
 16. The method of claim 1 wherein the agent for reversingthe effects of the anticoagulant is selected from the group consistingof sodium chloride, calcium gluconate and heparinase.
 17. The method ofclaim 1 wherein the filter material is glass wool.
 18. A method ofdelivering a composition to a patient comprising: centrifuginganticoagulated blood to obtain a platelet rich plasma; placing a firstportion of the platelet rich plasma in a first syringe body; adding tothe first syringe body an agent for reversing the effects of ananticoagulant within the first portion of the platelet rich plasma andallowing a clot to form within the first syringe body; placing a secondportion of platelet rich plasma in a second syringe body; deliveringthrombin from the first syringe body to the patient by squeezing theclot contained in the first syringe body through a filter material; anddelivering simultaneously the second portion of the platelet rich plasmafrom the second syringe body to the patient to combine with the thrombindelivered to the patient from the first syringe body to form a plateletgel composition.
 19. The method of claim 18 wherein the first and secondsyringe bodies have a luer connector at one end.
 20. The method of claim19 wherein an applicator tip comprising first and second luer fittingsis connected to the luer connectors of the first and second syringebodies.
 21. The method of claim 20 further comprising the step ofplacing the first and second syringe bodies in a holding mechanism thatretains the syringe bodies in parallel alignment without contacting saidfirst and second syringe bodies, the holding mechanism comprising anelongated support member positioned between the first and second syringebodies and having a pair of C-shaped clamps extending laterally from oneend of the elongated support member for attachment to the applicator tipluer fittings.
 22. The method of claim 18 wherein the first and secondsyringe bodies have first and second plungers, respectively, fordelivering from each of the syringe bodies its associated material, thefirst and second plungers each having a push flange and a plunger shaft.23. The method of claim 22 further comprising the step of placing thepush flanges of the first and second plungers in a plunger clip havingfirst and second channeled grooves for securing the plunger push flangeswithin the first and second grooves and actuating the plungerssimultaneously.
 24. The method of claim 23 wherein the first syringebody has a first length and the second syringe body has a second length,the first syringe body length being a different length than the secondsyringe body length and the first and second grooves of the plunger clipare longitudinally offset by an amount that is substantially the same asthe difference in the lengths of the first and second syringe bodies.25. The method of claim 18 wherein the platelet gel composition formswithin a wound site of the patient.
 26. The method of claim 18 whereinthe anticoagulant is sodium citrate.
 27. The method of claim 18 whereinthe anticoagulant is heparin.
 28. The method of claim 18 wherein theanticoagulated blood is centrifuged at a rate of about approximately 20to 50 r.c.f.'s.
 29. The method of claim 18 wherein the anticoagulatedblood is centrifuged for about approximately 10 to 40 minutes.
 30. Themethod of claim 18 wherein the anticoagulated blood is centrifugedrefrigerated at about 25 r.c.f.'s for about 20 minutes.
 31. The methodof claim 18 wherein the first syringe includes a contact activator tospeed up the formation of the clot.
 32. The method of claim 31 whereinthe contact activator is selected from the group consisting of glass,glass wool, silica, aluminum, diatomaceous earth and kaolin.
 33. Themethod of claim 18 wherein the agent for reversing the effects of theanticoagulant is selected from the group consisting of sodium chloride,calcium gluconate and heparinase.
 34. The method of claim 18 wherein thefilter material is glass wool.
 35. A method of delivering a compositionto a wound site of a patient comprising: providing a delivery devicecomprising first and second syringe bodies having first and secondplungers, respectively, and a plunger clip, the first and secondplungers each having a push flange and a plunger shaft, the plunger clipbeing capable of securing the first and second push flanges andactuating the first and second plungers simultaneously; obtaining aplatelet rich plasma containing an anticoagulant; placing a firstportion of the platelet rich plasma in the first syringe body; adding tothe first syringe body an agent for reversing the effects of theanticoagulant and allowing a clot to form within the first syringe body;placing a second portion of the platelet rich plasma in the secondsyringe body; delivering thrombin from the first syringe body to thepatient by squeezing the clot contained in the first syringe bodythrough a filter material; and delivering simultaneously the secondportion of the platelet rich plasma from the second syringe body to thepatient to combine with the thrombin to form a platelet gel composition.36. The method of claim 35 wherein the push flanges are of differentwidths.
 37. The method of claim 35 wherein the first and second syringebodies have a luer connector at one end.
 38. The method of claim 37wherein an applicator tip comprising first and second luer fittings isconnected to the luer connectors of the first and second syringe bodies.39. The method of claim 38 further comprising the step of placing thefirst and second syringe bodies in a holding mechanism that retains thesyringe bodies in parallel alignment without contacting said first andsecond syringe bodies, the holding mechanism comprising an elongatedsupport member positioned between the first and second syringe bodiesand having a pair of C-shaped clamps extending laterally from one end ofthe elongated support member for attachment to the applicator tip luerfittings.
 40. The method of claim 35 wherein the anticoagulant is sodiumcitrate.
 41. The method of claim 35 wherein the anticoagulant isheparin.
 42. The method of claim 35 wherein the step of obtaining aplatelet rich plasma containing an anticoagulant includes centrifuginganticoagulated blood at a rate of about approximately 20 to 50 r.c.f.'s.43. The method of claim 35 wherein the step of obtaining a platelet richplasma containing an anticoagulant includes centrifuging anticoagulatedblood for about approximately 10 to 40 minutes.
 44. The method of claim35 wherein the step of obtaining a platelet rich plasma containing ananticoagulant includes centrifuging anticoagulated blood refrigerated atabout 25 r.c.f.'s for about 20 minutes.
 45. The method of claim 35wherein the first syringe includes a contact activator to speed up theformation of the clot.
 46. The method of claim 45 wherein the contactactivator is selected from the group consisting of glass, glass wool,silica, aluminum, diatomaceous earth and kaolin.
 47. The method of claim35 wherein the agent for reversing the effects of the anticoagulant isselected from the group consisting of sodium chloride, calcium gluconateand heparinase.
 48. The method of claim 35 wherein the filter materialis glass wool.
 49. A method of preparing a composition for delivery to apatient comprising: providing a delivery device comprising first andsecond syringe bodies having first and second plungers, respectively,and a plunger clip, the first and second plungers each having a pushflange and a plunger shaft, the plunger clip being capable of securingthe first and second push flanges and actuating the first and secondplungers simultaneously; obtaining a platelet rich plasma containing ananticoagulant; placing a first portion of the platelet rich plasma inthe first syringe body; adding to the first syringe body an agent forreversing the effects of the anticoagulant and allowing a clot to formwithin the first syringe body; and placing a second portion of theplatelet rich plasma in the second syringe body.
 50. The method of claim49 wherein the push flanges are of different widths.
 51. The method ofclaim 49 wherein the first and second syringe bodies have a luerconnector at one end.
 52. The method of claim 51 wherein an applicatortip comprising first and second luer fittings is connected to the luerconnectors of the first and second syringe bodies.
 53. The method ofclaim 52 further comprising the step of placing the first and secondsyringe bodies in a holding mechanism that retains the syringe bodies inparallel alignment without contacting said first and second syringebodies, the holding mechanism comprising an elongated support memberpositioned between the first and second syringe bodies and having a pairof C-shaped clamps extending laterally from one end of the elongatedsupport member for attachment to the applicator tip luer fittings. 54.The method of claim 49 wherein the anticoagulant is sodium citrate. 55.The method of claim 49 wherein the anticoagulant is heparin.
 56. Themethod of claim 49 wherein the step of obtaining a platelet rich plasmacontaining an anticoagulant includes centrifuging anticoagulated bloodat a rate of about approximately 20 to 50 r.c.f.'s.
 57. The method ofclaim 49 wherein the step of obtaining a platelet rich plasma containingan anticoagulant includes centrifuging anticoagulated blood for aboutapproximately 10 to 40 minutes.
 58. The method of claim 49 wherein thestep of obtaining a platelet rich plasma containing an anticoagulantincludes centrifuging anticoagulated blood refrigerated at about 25r.c.f.'s for about 20 minutes.
 59. The method of claim 49 wherein thefirst syringe includes a contact activator to speed up the formation ofthe clot.
 60. The method of claim 59 wherein the contact activator isselected from the group consisting of glass, glass wool, silica,aluminum, diatomaceous earth and kaolin.
 61. The method of claim 49wherein the agent for reversing the effects of the anticoagulant isselected from the group consisting of sodium chloride, calcium gluconateand heparinase.
 62. The method of claim 49 wherein the first syringebody includes a filter material.
 63. The method of claim 62 wherein thefilter material is glass wool.